BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH SOFSILK 2/0 48 BLCK DLU SU

    MDR report key: 3964161 · Received May 22, 2014

    Report

    Report Number
    9612501-2014-00158
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP REPAIR OF ESOPHAGEAL HIATUS HERNIA. ACCORDING TO THE REPORTER: DURING USE OF THE SECOND RELOAD, THE NEEDLE WAS BROKEN INTO TWO AT THE VERY END OF THE LIGATION. AFTER REMOVAL FROM THE PATIENT THE SURGEON CONFIRMED PART OF THE NEEDLE WAS ATTACHED TO THE SUTURE. ANOTHER BROKEN PART COULD BE RETRIEVED FROM PATIENT. CONFIRMED THERE WAS NO MISSING PARTS IN THE PATIENT. A NEW RELOAD WAS OPENED. THERE WAS NO PATIENT HARM. THE OPERATING TIME WAS NOT EXTENDED. THERE WAS NO ADDITIONAL TISSUE RESECTION OR TISSUE DAMAGE. A PIECE FELL INTO THE CAVITY AND COULD BE RETRIEVED, BUT THERE WAS NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306912 ENDO STITCH SOFSILK 2/0 48 BLCK DLU SU DISPOSABLE SUTURING DEVICE KOG COVIDIEN J2L0304X

    Patients

    Seq Age Sex Outcome Treatment
    1